• Regulatory NewsRegulatory News

    FDA OKs new pathology AI software, launches AI-enabled device database

    The US Food and Drug Administration (FDA) has authorized software designed to help pathologists detect prostate cancer in digitally scanned slides from prostate biopsies. Separately, the agency announced Wednesday that it has made available a list of devices that use artificial intelligence and machine learning.   The newly authorized software, called Paige Prostate, is the first artificial intelligence (AI) tool okayed by FDA for in vitro diagnostic use for prostate...
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    Global regulatory workforce nearly 100K, says new report from RAPS, Elemed

    Nearly 100,000 professionals around the world currently work in the field of regulatory affairs for healthcare products, such as pharmaceuticals, medical devices, and biotechnology products, including vaccines. This is according to a new joint report from RAPS and Elemed , a leading technical recruiter specializing in regulatory affairs. The Global Regulatory Affairs Professionals Workforce report, previewed this week at the RAPS Convergence 2021 virtual conference...
  • Feature ArticlesFeature Articles

    August’s Regulatory Focus: Alternative regulatory pathways

    Feature articles during August focused on alternative global regulatory pathways and their use in providing faster, easier access to new treatments for unmet medical needs. Articles examined emergency use authorizations for in vitro diagnostics (IVDs) in the US, as well as regulatory pathways for laboratory developed tests (LDTs), innovative medicinal products in Switzerland, software as a medical device (SaMD) in the US and Europe, and cell and gene therapy products in Ja...
  • Feature ArticlesFeature Articles

    New method to an old approach: A semiquantitative approach for determining probability of regulatory success for ASEAN markets

    An objective assessment guide for estimating the likelihood of obtaining regulatory approval for marketing authorization applications submitted to local regulatory agencies is critical to facilitate commercial launch planning. In this paper, we describe a harmonized guide designed to estimate the probability of regulatory success (PRS) in the Association of Southeast Asian Nations (ASEAN). This guide focuses on a standardized set of criteria for semiquantitative assessment...
  • RF Quarterly

    RF Quarterly, June 2021: Artificial intelligence in global regulatory practice

    Welcome to the summer issue of RF Quarterly in which international experts from the UK, EU, Saudi Arabia, Hong Kong, and the US have come together to examine and dissect the role of artificial intelligence (AI) in healthcare and its impact on global regulatory practice.   Advances in AI technologies are transforming healthcare delivery and hold promise for improving patient outcomes. However, these complex technologies have introduced new challenges, especially aroun...
  • RF Quarterly

    Artificial intelligence: Characteristics, regulatory compliance, and legislation

    This article provides an introduction to artificial intelligence (AI), its characteristics, and how those characteristics affect regulatory compliance. It also examines efforts to regulate the ethical aspects of AI in the EU, future legislative initiatives that may affect AI in medical devices, and the crucial role standards play in supporting legislation.*   Introduction Although different people may understand artificial intelligence (AI) differently, it has been...
  • RF Quarterly

    Modernizing medical devices regulation for AI and ML: GHWP efforts

    The recent progress of artificial intelligence (AI) technologies has had a pivotal impact on the healthcare system. Medical device manufacturers use these technologies to develop new and innovative products for better health outcomes. However, these technologies have introduced new challenges to the medical field. There is a need to have a novel medical device regulatory framework that addresses these challenges. This article addresses the impact of AI on the medical devic...
  • RF Quarterly

    Regulatory update for SaMD and AI product approvals in China

    This article outlines the status of regulation for software as medical device (SaMD) in China, with particular focus on medical software using artificial intelligence (AI) technology. The market approval pathways are reviewed, and key sticking points discussed. Recent regulatory updates in this fast-moving area are presented, together with various product approval examples.   China’s medical software regulatory framework The term “medical device” is defined widely ...
  • RF Quarterly

    Enabling the digital transformation of industry: The roles of AI, big data, analytics, and related data ecosystem

    This article outlines the work of SC 42, the technical subcommittee for artificial intelligence (AI) of the ISO/IEC’s joint technical committee 1, which aims to accelerate adoption of the standards while simultaneously addressing emerging issues to enable successful digitalization of sectors.   Introduction and overview The digital transformation of industry promises to revolutionize how we live, work, and play, unlocking the vast potential of new use cases and ap...
  • RF Quarterly

    Synthetic data and the innovation, assessment, and regulation of AI medical devices

    Synthetic data are artificial data that mimic the properties of and relationships in real data. They show promise for facilitating data access, validation, and benchmarking, addressing missing data and under-sampling, sample boosting, and the creation of control arms in clinical trials. The UK Medicines and Healthcare products Regulatory Agency (MHRA) is using its current research into the development of high-fidelity synthetic data to develop its regulatory position on ar...
  • Regulatory NewsRegulatory News

    CDER regulatory science division touts 2020 accomplishments

    In its 2020 annual report, the division of the US Food and Drug Administration (FDA) tasked with addressing emerging regulatory issues and developing new tools and approaches for regulatory reviews said it was able to expand its efforts despite the COVID-19 pandemic impacting most of the year.   “2020 was a challenging year. In addition to adjusting to new work environments related to the COVID-19 pandemic that involved 100% teleworking for some staff and laboratory wo...
  • Feature ArticlesFeature Articles

    April’s Regulatory Focus: Professional and career development

    Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Included were articles on the mid-career transition from research scientist to regulatory professional, continuous professional development and the value of graduate-level qualifications, and findings from two surveys on different aspects of the profession. Other articles examined communication – one on persuasive skills, another on dissemin...